Custom formed natural fit artificial breast appliance

ABSTRACT

The breast appliance and method of making of the present invention is adaptive to a variety of situations ranging from a first embodiment where impressions of both breasts of a client are available for molding, a second embodiment where a single breast is available for molding, a third embodiment where a sensitive nipple or an augmentative breast appliance is to be formed, and a fourth embodiment where breast appliances are formed from a client having neither breast available for molding. 
     If client&#39;s impression is made before surgery, a positive impression can be made directly from a negative mold. A molded silicone form or clay form is used to prepare a breast appliance front mold and a breast appliance back mold. Skin type nipple and breast skin silicone is first introduced into the mold before closure. After closure, a silicone gel is introduced into the cured skin silicone envelope, with removal of air and bubbles using an exit tube. After complete curing the breast appliance is removed from the mold, and worn against the surgical area with an ordinary bra, or directly onto the client&#39;s chest wall using a liquid adhesive to adhere the appliance to the body.

This is a continuation of co-pending application Ser. No. 08/447,793filed on May 23, 1995, now abandoned, which was a continuation ofapplication Ser. No. 08/267,104 filed on Jun. 23, 1994, now abandoned.

FIELD OF THE INVENTION

The present invention relates to the field of external breast appliancesand more particularly to a custom fitted natural external structure,known as an appliance which may be worn continuously for days, and whichis most difficult to distinguish from the natural skin's surface.

BACKGROUND OF THE INVENTION

Artificial breast appliances have been employed for use over a range oftime and workability. At its simplest, artificial breast appliances havetaken the form of a weight of external material to be added to a bra,both for form and weight. At their most complex, artificial breastdevices have been implantable, requiring a surgeon's skill and materialsfree from defect.

In between these two extremes, one of the most useful appliances wouldbe one which was custom designed for the user, which could be wornnaturally with or without the supportive contribution from a bra andwhich could be worn for several days and under the same conditions andcircumstances as a natural breast. However, the prior art devices havefallen short of this goal.

For Example, U.S. Pat. No. 4,086,666 to Vaskys et al. and entitled"Breast Prosthesis," discloses a process for making an artificial breastappliance. The steps include (1) the making of a negative body cast, (2)grooving the cast to provide air circulation, (3) making a positive castof the negative cast with fiberglass, (4) modeling the missing breast onthe positive cast, (5) forming a silicone rubber mold over the sculptedmissing breast and adjacent areas, (6) forming a support casting overthe silicone rubber mold, (7) forming a breathing dome on the positivecast, which is much smaller than the breast to be replaced, (8) a funnelshaped opening is modeled in the dome, and diagonal cuts are formed, (9)two vinyl pads are placed on the positive cast, (10) silicone rubber isapplied in thin layers to the positive cast to form a back wall, (11)colored silicone rubber is painted onto the mold supported by thesupport casting to simulate the coloring of the wearer, (12) wovenDacron is added to the mold, (13) the support casting is added to thepositive cast, and (14) the space between the support casting andpositive cast is filled. The prosthesis of Vaskys et al is removed andmay be held in place with two sided adhesive surgical tape.

In U.S. Pat. No. 4,401,492, issued to Pfrommer and entitled "BreastProsthesis and Method of Making Same, " a two layer rubber skin isfilled with a liquid and supported by a stiff walled backing. Here, thesteps include (1) the making of a negative body cast, (2) making apositive cast of the negative cast with fiberglass, (3) sculpting themissing breast on the positive cast, (4) forming a silicone rubber moldover the sculpted missing breast and adjacent areas, even up to theshoulder and formed from "Silastic G" type silicone rubber and aboutone-eighth of an inch thick, (5) forming a support casting over thesilicone rubber mold, (6) a retaining wall is constructed about theperimeter of the support casting, (7) once the retaining wall and volumematerial are joined, the cavity is filled with fiberglass reinforcedresin, and (8) the formed shape is dipped in generally flesh coloredsilicone. Later steps include the filling with silicone gel so that thesize of the artificial breast may be enlarged or reduced in sizedepending upon weight gains and losses of the wearer.

U.S. Pat. No. 3,811,133 issued to Eugene Harris and entitled "WeightedProsthetic Breast" discloses a molded breast filled with resilientwadding and which is weighted from the rear of the prosthesis. Althoughbegan from the molding process, along with some clay sculpture, themolded form is cut open to stuff in the wadding.

Another method to attempt to provide an appliance is the pocket bra inwhich a backing cloth material is provided in a bra behind the frontalcup material, to accommodate the insertion of a plastic or other coneshaped appliance. These bras can be problematic especially if theinserted appliance is turned with respect to its fitted resting place,producing an odd-shaped appearance. Since the opening of the pocket bramust be large enough for the cone shaped appliance to fit within, theopening has presented opportunities for the appliance to slip out,particularly when the wearer bends to pick up something. Even moreembarrassing, the cone shaped appliance and the bra portion holding thecone shaped appliance can, even if the wearer is bent only slightlyforward, gravitationally separate from the chest of the wearer to thusexpose the surgical scar tissue and the surface of the rear of thepocket bra. Further, if the bra material has weakened, the appliance mayfall up to twice as far from the wearer as the wearer's other breast,and thus appear extremely unnatural.

SUMMARY OF THE INVENTION

The breast appliance of the present invention is made by first taking animpression of both breasts of a client, if possible, or the client'schest after surgery. It is preferred to have a mold of the client'sbreasts before surgery if possible. If client's impression is madebefore surgery, a positive impression can be made directly from anegative mold.

A color match is made with respect to the client's existing skin tones,breast tissue, and nipple tissue. As used herein, the term "nipple"includes the areolar skin and any skin which projects as nipplematerial. Skin tones may include olive dark, ruddy dark, olive light,ruddy light, transparent, and charcoal to name a few. The clay fittingis made with respect to the client's bras to determine a good fit andwith respect to a balancing of weight.

Where no pre-surgical impression is available, the clients nipple froman existing breast is then measured and a nipple impression from theclient's own nipple, if possible, is taken using alginate or a mixtureof such materials.

A negative alginate impression is then made of the client's torso area,with plaster bandages applied to the outside of the alginate forstrength and stability. A positive form is then made from the negativealginate impression. The positive form can be used in conjunction with aclay breast model and nipple form, the clay breast model shaped onto thepositive form, and test fitted with the client's bra to ensure evennessand fit. Alternatively, the negative pre-surgical chest mold can be usedwith any material to form a mold of the client's original breast shape.

A back mold can then be made either from the positive body mold, or fromanother negative mold taken from the client's chest. The back mold istypically made of plaster poured against the negative mold. Then thebreast form and silicone nipple is added onto the negative mold and thefront mold is poured over the back mold, the breast form, and thesilicone nipple mounted thereon, which will form a breast appliancemold. The breast form is removed and the inside of the breast appliancemold is finished, including a beveled interstitial area formed on thebreast appliance front mold. Skin-type silicone is then applied to theinner surfaces of both halves of the breast appliance mold, the mold isclosed, and silicone gel is introduced to the volume enveloped by theskin-type silicone material with the use of a fill tube extendingthrough a drilled bore of the back mold.

Once the gel material cures, the formed breast appliance is carefullyremoved from the breast appliance mold.

In preparation for making the breast appliance mold, severalalternatives are available. In one alternative, a clay fitting is madebased upon client preferences. In another, a volume may be molded fromany suitable material made in a pre-operative negative body mold.

A nipple impression may be made, if one of the client's nipples isavailable. Other matching techniques are available to match not only theclient's skin color, but other skin characteristics including freckles,veins and internal structuring.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention, its configuration, construction, and operation will bebest further described in the following detailed description, taken inconjunction with the accompanying drawings in which:

FIG. 1 is a front view of a torso of a client with both breasts presentavailable before surgery and having an application of alginate appliedto the torso area while the client's torso is in an upright position;

FIG. 2 is a front view of a torso of a client after the alginate shownapplied in FIG. 1 is set, and illustrating plaster bandages applied overthe alginate set to give greater structural strength to the torsoimpression and to form a negative mold;

FIG. 3 is an illustration of the removal of the negative mold formed inFIGS. 1 and 2 being removed from the client;

FIG. 4 illustrates the pouring of plaster into the negative mold shownin FIGS. 1-3 to form a plaster positive body mold;

FIG. 5 illustrates the removal of the negative body mold from thepositive body mold;

FIG. 6 illustrates the taking of an alginate mold of the breast nipplearea, separate and apart from the molds of FIGS. 1-5;

FIG. 7 illustrates a front view of a torso of the client shown in FIGS.1-6, but after surgery and having an application of alginate applied tothe torso area to take an impression of the tissue formed after surgery;

FIG. 8 is a front view of a torso of a client after the alginate shownapplied in FIG. 7 is set, and illustrating plaster bandages applied overthe alginate set to give greater structural strength to thepost-operative torso impression and to form a post-operative negativemold;

FIG. 9 is an illustration of the removal of the post-operative negativemold formed in FIGS. 7 and 8 being removed from the client;

FIG. 10 illustrates the post-operative positive body mold formed fromthe post-operative negative mold shown in FIGS. 7-9 by the method shownin FIGS. 4 and 5, and illustrating a scar tissue area identified forfurther molding;

FIG. 11 illustrates an alginate impression being taken with respect to asingle breast area of the post-operative positive body mold shown inFIG. 10;

FIG. 12 illustrates the surrounding of the smaller alginate impressiontaken in FIG. 11 with a sealable barrier before plaster is poured ontothe smaller alginate impression to form a breast appliance back mold;

FIG. 13 illustrates the removal of the sealable barrier exposing thebreast appliance back mold;

FIG. 14 illustrates the removal of the smaller alginate impression fromthe breast appliance back mold;

FIG. 15 illustrates the rear side of the pre-operative negative bodymold and the formation of a positive breast form impression therewith;

FIG. 16 illustrates the positive breast form being mounted atop thebreast appliance back mold;

FIG. 17 illustrates the configuration of FIG. 16 being surrounded by asealable barrier of a height sufficiently greater than the breast formwhile mounted atop the breast appliance back mold;

FIG. 18 illustrates the pouring of plaster into the structure shown inFIG. 17, the upper layer of plaster to form a breast appliance frontmold;

FIG. 19 illustrates the structure shown in FIG. 18 once the upper layerof plaster has set, and the sealable barrier has been removed;

FIG. 20 illustrates a rear view, looking into the cavity formed in thebreast appliance front mold once the breast form has been removed andillustrating the details which must be selectively finished to ensure asuitable finish on a resulting breast appliance;

FIG. 21 illustrates a cross sectional view of the rim of the breastappliance front mold taken through line 21--21 of FIG. 20 to illustratethe tapering surface formed in the finishing process;

FIG. 22 illustrates the drilling of a pair of holes into the breastappliance back mold;

FIG. 23 illustrates the positioning of a pair of tubes within thedrilled holes illustrated in FIG. 22;

FIG. 24 illustrates the application of nipple colored silicone to thenipple portion of the breast appliance front mold;

FIG. 25 illustrates the application of breast skin colored silicone tothe non-nipple portion of the breast appliance front mold;

FIG. 26 illustrates the application of breast skin colored silicone tothe breast appliance back mold and surrounding the area where the tubesshown in FIG. 23 abut the scar tissue impression surface;

FIG. 27 illustrates the joining of the breast appliance back mold overthe breast appliance front mold and the strap securing them together, aswell as silicone filler fluid being introduced into the fill tube;

FIG. 28 illustrates the breast appliance front mold after the filler andair displacement tubes have been removed, and illustrating the rearportion of the breast appliance and the careful removal of the taperingarea of the breast appliance from the breast appliance front mold;

FIG. 29 illustrates the removed breast appliance;

FIG. 30 illustrates application of a body adhesive to the rear of thebreast appliance, and showing the sealed area where the filler tubesextended into the breast appliance;

FIG. 31 illustrates the breast appliance mounted on the client andshowing the outer extent of the breast appliance in dashed line format;

FIG. 32 illustrates an alternate procedure where only one breast isavailable for molding and in which the post-operative positive body moldfrom FIG. 10 is used as a base upon which a clay breast, with siliconenipple, is molded;

FIG. 33 illustrates the sculpting of a clay breast form upon a positivebody mold;

FIG. 34 illustrates the use of the clay form of FIG. 33, mounted withsilicone nipple and resting above a breast appliance back mold andreadied for pouring of the breast appliance front mold;

FIG. 35 illustrates a positive body mold made from a client havingsensitive post-operative nipple tissue which must be protected fromrubbing and compressive contact with a breast appliance;

FIG. 36 illustrates the use of small clay shapes upon the sensitivenipple shapes of the positive body mold of FIG. 35 to produce a nippleclearance area in the resulting breast appliance;

FIG. 37 illustrates a breast appliance back mold produced from thepositive body mold shown in FIG. 36;

FIG. 38 is a sectional view of a breast appliance taken along line38--38 of FIG. 29, and illustrating both a small structural air pocketfor the appliance nipple, as well as the nipple pocket;

FIG. 40 illustrates the data gathering process, in lieu of a negativebody mold, which can be used to generate both negative and positive bodymolds, as well as direct formation of a breast appliance mold;

FIG. 41 illustrates the scanning in of data directly, covering all datapoints, with the use of a scanner;

FIG. 42 is a sectional view of a breast appliance designed to have astructure to permit more natural movement and having a structure whichwill enable simulation of the client's pre-operative breast displacementunder movement conditions.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The description and operation of the invention will be best begun withan explanation of the three ways with which the invention hereof may bebegun. In case 1, a client has available for molding either one or bothof the breasts which will later be removed, and for which the formationof a breast appliance is necessary. In case 2, a client has one breastpresent, and desires a breast appliance to be formed over the area ofthe missing breast. In case 3, a client has no breast available formolding, and requires a pair of appliances derived from a personalselection of size, shape, and nipple configurations. In another case,the client requires only a nipple prosthesis.

Referring to FIG. 1, and beginning with case 1, a client 51 with bothbreasts in tact before undergoing surgery is available. Many surgeriesare exploratory with further surgical action occurring while the clientis on the operating room table based upon laboratory results. It istherefore suggested that even potential mastectomy candidates beavailable for molding their chest area based upon the possibility that amastectomy may be performed even when the client 51 is going in for aminor biopsy. If no surgery is performed, the impression of the chestarea can be retained for a time and later destroyed as the client's bodywill after a time may no longer resemble the earlier impression.

While the client 51 is present, and either before or after the chest ismolded, the client 51's skin color and nipple color is matched. Althoughascertaining the client's skin and nipple color can be done by a varietyof methods, one which has worked quite well is the visual matching ofcolor simultaneous with the formation of the silicone materials whichwill form the breast appliance. Simple, commercially available facepowder is available in a variety of colors and may be admixed withsilicone to form a suspension having color and depth tones comparablewith skin.

With the breast appliance to be made, three color areas need beconsidered. First, there is the color of the nipple. It is importantthat the color be matched pre-operatively to insure that longer lastingskin color changes in some clients will not cause the construction of abreast appliance which will not match after a significant time period.

The second color is the skin color of the breast exterior, and the thirdcolor is the color of the breast interior. Where veins are present, theymay be simulated with lengths of fabric which will be suspended withinthe constructed breast appliance.

An amount of silicone starting material in excess of that which will beneeded is mixed and matched against the pre-operative skin, areolar,nipple and breast tones, and then stored. Where significant amounts of asetting agent is to be used, it too can be matched and stored. Thepractitioner should beware the matching of color tones based upon onevolume of silicone material where significant amounts of anothermaterial will be added to cause the silicone to set. This is especiallytrue for the material to be used inside the breast appliance which willform the greater volume of the breast appliance, and whose proportion ofmixing will depend on the structural consistency desired for the breastappliance ranging from firm to very soft.

In case 1, the client 51 is to have a mold made of the chest area.Preferably the mold will be made from points on the chest at least aslow as a few inches below the bottom of the rib cage, to a few inchesabove the clavicle area, and at least as wide as halfway to the mid lineextending below the arm pit area. The molding of the chest is shown inFIG. 1.

In the molding process, the shape of the breast in the standing, lying,and bra covered positions are considered. Since the breast appliancewill typically be used in the standing position, its orientation whenthe client 51 is reclined is given preference. Further, the standingposition may be modified to take to account whether the client 51 willuse the appliance in a bra. This is because a client 51 with soft, butsagging breasts will elect a shape which more closely approximates theshape of the breast as would exist in a bra.

Further the client 51 can, if she is not satisfied with her naturalbreast shape, elect to have breast appliances made which will improveher look. However, where the client's breasts have an appearanceacceptable to the client 51 in the standing position, a mold is made ofthe chest area.

The first step in the mold process is to obtain an alginate impressionmaterial. One such commercially available alginate impression materialis sold under the trade name IDENTIC and is made by Cadco DentalProducts, Inc., of Oxnard, Calif. This type of material is able toreproduce extreme surface detail. The preferred material is a dust free,five minute setting material. The five minute setting material may besomewhat more difficult to obtain, since most dental applicationsrequire a faster setting time. In taking a chest impression, severalminutes may be required to apply the material, as well as to allow thematerial to take on the chest skin texture. A faster drying material maycause a less faithful impression or may cause the applicator to takefurther steps to minimize the mixing and application time.

The alginate material is in the form of a powder and is mixed withwater. Varying the amount of water enables the applicator to vary theviscosity and thickness of material being applied to the client's chestarea. The recommended amount of water for one type of alginate has been16.0 cc of water per 6.0 grams of dry alginate powder.

Once a sufficient amount of alginate has been prepared with warm water,an alginate layer 53 is applied to the client 51's chest while theclient 51 is preferably in a standing position. In standing position,the breasts take on the most desirable orientation. If the client 51wishes modifications, or even several sets of different breastappliances with different orientations, such may be formed later, aftersurgery, in addition to the impressions taken at this early stage.

The alginate sets in five to ten minutes. However, because the alginateis present in a relatively large mass with a relatively small thicknessof from one fourth to one half of an inch across the client's chest,more structural support is needed to both remove and handle the alginatenegative case which is formed of the client's chest.

For this additional support, plaster bandages 55 are applied to theexternal surface of the cured alginate layer 53, as is shown in FIG. 2.Plaster bandages 55 are loosely woven gauze strips which are availableimpregnated with plaster. All that need be done is to dip the plasterbandage roll into a supply of warm water, squeeze out the excess water,and apply directly to the alginate material in a crossing pattern. Atriple application of the triple crossing pattern is recommended forstrength. Setting time for the plaster bandage may range from two toeight minutes. A further supply of plaster may, if necessary, be smearedover the plaster bandages 55 to form a more reinforced mass, perhapsfollowed by further application of plaster bandages 55. Such a techniquemay be necessary where there is not enough plaster in the plasterbandages 55.

Also consider the use of a refrigerator or other method to cool thebandages to reduce the any shrinkage which may occur. Once the plasterbandages 55 have dried and hardened, a negative mold 57 of the client51's chest is formed and is removed gently from the client 51, as isshown in FIG. 3. Next, a positive body mold is formed by pouring aplaster mixture 59 into the negative mold 57. Once the plaster dries andhardens, it becomes positive body mold 61, and the negative mold 57 isremoved from around it as is shown in FIG. 5. A chest sized positivebody mold 61 is important because it has sufficient mass and structuralintegrity to enable further work and will not easily break.

As will be explained, the molds from which the breast appliance isformed will be neither the negative mold 57 nor the positive body mold61. This is so for several reasons. First, if wither of the two molds 57or 61 were damaged in formation of the breast appliance (to be shown),which formation always occurs after surgical breast removal, theimpression would be lost. Secondly, handling the relatively larger moldsto make a relatively small breast appliance would be unduly bulky andonerous. Third, the sealing pressure needed to be exerted between thehalves of the mold which form the breast would come close to breakingthe larger molds. Fourthly, and as will be shown, some material in thenegative breast mold will need to be removed to provide a thin taperingarea of silicone which will be used to "blend" in with the skin of theclient 51.

Therefore, although a negative breast mold is formed as a part of thenegative mold 57, a further negative breast mold will be formed, as willbe shown later. In accord with other cases in addition to case 1, aseparate alginate mold may be taken of the client 51's nipples. This maybe particularly the case where the client 51's nipples are formed of anunusual shape or having an extended center portion. This step can alsobe used in a case where an implant is elected after a mastectomy, and anipple alone may be made to adhesively fit over the tissue in which theimplant is placed. Especially in the case where an implant might beelected, a separate nipple mold needs to be made.

A separate nipple mold can be made with reference to FIG. 6 by applyingthe alginate material in a suitable layer 53 to the client 51's nipple63, and an inch of additional diameter beyond the client 51's areolar65. There may or may not be a small section of plaster bandage 55applied to the outer surface of the alginate to add support and help toretain the surface contour of the breast immediately about the nipplearea. Typically, a silicone nipple can then be formed directly bybrushing appropriately colored silicone, with its setting agent into anipple mold 67 formed by the procedure shown in FIG. 6. The details forforming the nipple material will be described at further length below.

Once the client 51 has participated in the above procedures, a surgeryis typically performed which may leave the client 51 in one of severalstates. A large portion of one or both of the client 51's breasts mayhave been removed. The procedures vary widely, and the results can vary.One procedure may include the total removal of all nipple tissue and allbreast tissue, typically leaving a laterally extending scar layer on thechest tissue. Another procedure may result in removal of the bulk of thebreast material, but leaving the nipple in tact. In another caseadditional intertissue of excessable amount may be present. In thiscase, the client's nipple 63 may be very sensitive, not just after thesurgery, but permanently.

In another case, some breast material may be present, both in terms of aparticularized size and shape. For example, a radial half of the breastmay be removed leaving a smaller portion of the other half. In anotherexample, one or more folds of tissue may be left in an unattractive ordifficult configuration. Regardless of what shape and amount of tissueremains on a client 51's chest, the method described herein will takeaccount of it in forming the breast appliance of the present invention.

After the client 51 surgery, and the passage of a sufficient amount oftime for any swelling or inflammation to subside, a mold of the client51 chest is made. It is important not to make the mold too soon, beforehealing is completed, since further healing after a mold is made willreduce the fit of the breast appliance against the client 51 chest.

As can be seen in FIGS. 7-9, the client 51 as she appears post-surgerywhich resulted in a double mastectomy. There is scar tissue 71, and thealginate layer 53 is being laid over this scar material in a manneridentical to that shown in FIGS. 1-3, to form a post operative negativebody mold 73, as shown in FIG. 7-9. From the post operative negativemold 73, a post operative positive body mold 75 is formed, similar tothe procedure shown in FIGS. 4 and 5. It is the post operative body mold75 which will serve as the basis for the rear wall of the breastappliance of the present invention, as will be shown.

As previously mentioned, a smaller mass of material need be formed toact as mold for the breast appliance of the present invention, for andease of size. Beginning with the post operative body mold 75, andreferring to FIG. 11, a smaller amount of alginate layer 77 is spreadover one of the right and left scar areas of post operative body mold75. Enough of the smaller amount of alginate layer 77 is spread beyondthe base of the outline of the previously present breast to insure thatenough of the surrounding material will be cast from which a taperingedge can be formed.

After it has cured, the smaller alginate layer 77 may have plasterplaced against its outside to form a stronger structural form. In anyevent, smaller alginate layer 77 is then gently lifted from the postoperative body mold 75, as is shown in FIG. 11, and placed on a flatsurface, shown in FIG. 12. The side of the smaller alginate layer 77which faced the scar tissue of the post operative body mold 75 is placedupwardly with regard to a flat surface 79. Flat surface 79 may bemoveable, or it may be a table top.

Next, a flexible barrier 81 is formed into an annular cylinder andfurther formed to closely surround the smaller alginate layer 77, makingsure that the shape of the smaller alginate layer 77 is preserved in allthree directions. The end edges 83 are attached abutting one another toform a leak proof annular cylinder. The cylinder shape formed by theflexible barrier 81 may deviate from circularity as necessary to closelyconform to the edge of the smaller alginate layer 77. The space betweenthe end edges 83 and the space between the flexible barrier 81 and theflat surface 79 may be sealed with putty or clay, or any otherdisposable or workable material.

It is understood that the smaller alginate layer 77 could have beentaken directly from the client 51 without the need to form a positivebody mold 75. However, the positive body mold 75 has advantages ofenabling reference points, enabling measurement with a bra and generallyvisualizing the appearance which the client 51 is trying to achieve.Also, the formation of a positive body mold 75 will eliminate the needto take a smaller alginate mold of the portion of the client's chestwhere the breast appliance is to be located. This procedure can help tominimize client time and discomfort in that it brings to a minimum theclient 51's mold activity.

Next, a volume of plaster is poured into the area inside the flexiblebarrier 81 to form a shape approximating a cylinder whose operativesurface abutting the smaller alginate layer 77 will be an exact replicaof the client 51's post operative tissue, as well as the post operativetissue area of the post operative body mold 75.

Once the plaster has hardened to form a breast appliance back mold 85,as is shown in FIG. 13, the flexible barrier 81 is removed, and the backmold 85 is inverted, and the smaller alginate layer 77 is removed. Thebreast appliance back mold 85 is a negative mold of a surface whichshould abut the client 51's post operative chest area.

Next, a breast impression needs to be made from the negative mold 57.Care is made in selecting the material to be molded into the negativebody mold 57 to ensure that it captures the nipple detail of the client51. A mold release is typically sprayed into the appropriate breastcavity of the negative mold 57 to ensure that the mass placed thereinwill adequately capture the details of the pre-operative breast form.

Suitable releasing agents include soaps, stearic acid and kerosene,petroleum jelly, and spirits of camphor. It should be pointed out that asuitable releasing agent should be one which will not contaminate thesilicone. One such material which can be employed as a releasing agentis a spray lacquer. One such lacquer is sold under the name ZYNOLYTE andis commercially available from Compton, Calif.

Once a breast form 87 is molded from a firm silicone and removed fromthe breast cavity of the negative mold 53, as shown in FIG. 15, it isplaced atop the breast appliance back mold 85, as is shown in FIG. 16.The interface between the scar tissue surface of the breast applianceback mold 85 and the back side of the breast form 87 will not and is notexpected to match exactly. However, both the support and height of thebreast form 87 must be therefore taken to account to insure that breastform 87 sits properly atop the breast appliance back mold 85.

Referring to FIG. 17, the flexible barrier 81 is again brought aroundthe breast appliance back mold 85. Additional sealing may beaccomplished between the upper surface of the breast appliance back mold85 and the flexible barrier 81, but care must be taken to make sure thatthis is minimal and that any clay or putty sealer not touch any of thesurface of the breast appliance back mold 85 which carries the client51's impression. In addition, the edges and surfaces of the breastappliance back mold 85 are treated with a release agent to make surethat neither of the breast form 87 or the subsequently added plasterwill stick to it.

Referring to FIG. 18, an amount of additional plaster mixture 59 ispoured into the sealed flexible barrier 81 and over the breast form 87,totally covering it, and with sufficient additional plaster to insurethe structural integrity of what will become breast appliance front mold89 when the plaster shown being poured in FIG. 18 hardens and dries.

FIG. 19 illustrates the breast appliance front mold 89 overlying thebreast appliance back mold 85 with the flexible barrier 81 removed. Thebreast appliance front mold 89 is then gently separated from the breastappliance back mold 85, and the breast form 87 is then gently removedfrom the breast appliance front mold 89.

The next step will determine the surface finish of the breast appliance(still yet to be shown). Referring to FIG. 20, the breast appliancefront mold 89 is shown lying on its side, looking into the void whichwas previously occupied by the breast form 87. The inner surface, notincluding the nipple area, referred to as the breast mold surface area91 may be pitted and rough. A hand sanding operation is initiated withsand paper ranging from coarse to a successively finer grain. In someinstances where there are pits on the surface to be smoothed, such pitsmay be filled in with small amount of plaster swiped across the pit, andsanded down after drying and setting.

Care must be taken not to sand the nipple mold area, shown in FIG. 20with the numeral 93, as it is not intended to be smooth. If there areany gross defects or anomalies with respect to the nipple, they must beworked carefully with tools with a mind toward preserving the textureand form of the nipple. Once the nipple mold area 93 and breast moldarea 91 surfaces of the breast appliance front mold 89 is carefullyprepared, an amount of the breast appliance front mold 89 immediatelysurrounding the breast surface outer edge of the mold is to be removed.

This rim area 95 will be removed by removing slightly more materialimmediately adjacent the breast mold area 91 and removing only a verysmall amount of material immediately adjacent the outer cylindricalsurface of breast appliance front mold 89. Remembering that the rim area95, as originally formed, was an exact match with the opposing surfaceof the breast appliance back mold 85, a removal of material,particularly a larger removal of material nearer the concentricallyinner edge of the rim area 95 will enable any material placed betweenthe breast appliance front mold 89 and breast appliance back mold 85 tobe formed into a taper leading concentrically outwardly away from thecenter.

A detail of the removed material is illustrated in FIG. 21, with thearea which would otherwise be occupied by the material which was removedshown in phantom. The remaining surface is a beveled surface 97.

Next, and referring to FIG. 22, a pair of closely spaced holes 99 and101 are drilled completely through the breast appliance back mold 85.These holes are positioned nearest the portion of breast appliance backmold 85 which would correspond to the chest area nearest a vertical lineextending from the pit of the arm. This corresponds to a surface of theportion of the breast appliance back mold 85 which is lower than most ofits other surface. If the breast appliance back mold 85 were inverted,it would represent a higher fill area, and this is the reason for thepositioning of the holes.

A pair of tubes 103 and 105 are positioned in holes 99 and 101, as isshown in FIG. 23. The tube 103, which will be utilized for filling theassembled breast appliance mold with filler material extends about onehalf to one inch above the surface of the breast appliance back mold 85while the tube 104, which will carry displacement air, rises onlyslightly above the surface of the breast appliance back mold 85. Thelengths of the tubes 103 and 104 will preferably, on the other side ofthe breast appliance back mold 85 extend to a length of from ten totwelve inches. Preferably the breast appliance back mold 85 is checkedfor fit against the breast appliance front mold 89.

Next begins the steps for actual construction of the breast appliance.The colors which were matched using liquid silicone to which face powderwas added to achieve such color are retrieved from storage. Referring toFIG. 24, the inner surface of the breast appliance front mold 89 issprayed with a release agent, with care being taken that it does notunduly run or collect to one side. The breast appliance front mold 89may be inverted to ensure that the release agent does not collect, andif an excess is present it will run toward the base rim. The releaseagent may be carefully brushed into the nipple mold area 93 to ensurethat nipple details are not obscured.

Once the release agent has been sprayed into the mold, the nipplesilicone material is mixed with its setting agent, and it is paintedinto the nipple mold area 93. The nipple silicone material must be fullywetted and applied to the nipple mold area 93. In some cases an airbubble (to be shown later) may be deliberately formed behind thesmallest portion of the nipple to provide a more natural feel to thefinally formed breast appliance, since a small bubble of entrapped aircan compress and spring back in a manner more closely approximating thatof a natural breast. Alternatively, the volume of the extended portionof the nipple can be left open to be filled with the same gel which willfill the formed breast appliance. The structural integrity of the nipplecan be particularly important for interaction of the breast appliancewith clothing. The nipple tip end would have enough structural strengthto manifest a natural look with sheer clothing, but would not expressits shape through a more tightly worn bra. The same air bubble may beemployed in forming a separate nipple (as will be shown).

Referring to FIG. 24, a paint brush 107 is shown employed for addingnipple silicone material 109. A brush 107 may be used to ensure that thematerial is thoroughly spread into each tiny texture structure of thenipple mold area 93. One such nipple silicone material 109 is sold underthe trade name FACTOR II, from Lakeside, Ariz. Another material isavailable commercially from Nusil Technology under the designationCF16-2186, FACTOR II. Like most silicones, it is commercially availableas a volume of part "A" and a volume of part "B", which can besubsequently mixed to initiating setting. These components are alsoknown as "base" and "catalyst." The consistency of the material aftersetting up will depend upon the proportions of the "A" and "B" materialsselected.

Since a color match with just the "A" material will be diluted if the"B" material is added in an uncolored state, the color match may beaccomplished with respect to both volumes before those volumes are mixedtogether. Alternatively, the color match for part "A" may be made ashade darker to take account of the part "B" which will be added tocatalyze part "A," in addition to colored earth pigments and facepowders.

In addition to the addition of face powders, an amount of kaolin isadded to "fill" in the areas which will be colored by the face powderand add to the opaque, skin-like appearance. For nipples, typically 100grams of the 2186 silicone base (part "A") is mixed with two teaspoonsof kaolin. The 100 gram mix is then divided into 5 and 10 gram amounts.A given 10 gram container can then be used to match the nipple color ofthe client 51. It is recommended that the part "B" or catalyst be addedin a ratio of ten parts of base "A" to one part of catalyst "B." Thenipple silicone 2186 material should not be catalyzed until immediatelybefore use. It is preferred to draw a vacuum on the catalyzed mixture toensure that all bubbles are removed from the mixture. Bubbles can spoilthe consistency and texture of the nipple area formed on the breastappliance. Vacuum de-airation at 28 inches of Mercury is recommendedwhile holding the vacuum for 3 to 5 minutes. Once mixed, the pot time isfrom 10 to 20 minutes depending upon room temperature. The total curetime is from 4 to 6 hours, and again room temperature is a factor.

The silicone (CF16) 2186 material is left to set in the nipple mold area93 for 3 to 4 hours. It is important to allow the nipple silicone 2196material to completely set so that the coloration between the skin ofthe breast appliance being formed and the breast appliance nipplematerial will not intermix, obscuring the line of separation. The nippleformed will typically require about 2.5 grams of material. As such, someof the color matched nipple silicone 2186 material may be held back incase the breast appliance needs to be re-molded, or to have anotherapplication applied.

It is also at this time that a nipple structural air pocket can beformed. An air bubble left in the outermost projecting portion of thenipple will provide a more gentle structural projection for the tip endof the nipple from the breast appliance which more accurately simulatesa natural nipple. In sheer clothes the nipple on the breast appliancewill more readily express its shape and presence, while in morerestrictive clothes its expression will diminish. Without the nipplestructural air pocket, the expression of the tip of the nipple from thebreast appliance will be of greater magnitude even in restrictiveclothing, and will have a natural touch through the clothing. Further,the presence of the nipple structural air pocket will more accuratelysimulate a natural breast and nipple to the touch through the clothing.This nth degree of detail is often necessary for the complete confidenceof the client 51 in a breast appliance which will eliminate worry andundue attention to a breast appliance.

The nipple structural air pocket can be formed by first forming a flatround plate of nipple silicone material 109 and allowing it to curesufficient for a minimum amount of structural strength. Once the nipplemold area 93 is painted in with the nipple silicone material 109, theflat round plate of nipple silicone is placed to cover the lowermost"bore" which is the negative impression of the outermost portion of thenipple. The back of the flat round plate may be painted over withfurther amounts of nipple silicone material 109 to ensure that thenipple structural air pocket will be closed and not in fluid aircommunication with the silicone which will occupy the bulk of the breastappliance.

The nipple silicone 2186 material may be applied in a layer as thick asneeded, and may be from one eighth to one fourth of an inch thick. Thenipple silicone 2186 may also be air brushed into the nipple mold area93 if sufficient equipment is available, as well as a structure to blockany stray migration of nipple silicone material 109 onto other areas.Once the nipple silicone 2186 material is completely cured, the siliconefor the "skin " of the breast appliance is applied. The siliconematerial is also silicone 2186, and is also formed in a 10:1 ratio, aswas the case for the nipple material.

The weight of 2186 silicone material is dependent upon the size of thebreast appliance since a larger breast appliance will require moresurface area. In addition, a larger breast appliance will require athicker skin to adequately support the mass of silicone gel inside it.For a breast appliance corresponding to a bra cup in the range of "sizeA," to "size B," about 40 grams of the 2186 silicone material isrequired. For a breast appliance corresponding to a bra cup in the rangeof "size B," to "size C," about 60 grams of the 2186 silicone materialis required. For a breast appliance corresponding to a bra cup in therange of "size C," to "size D," about 80 grams of the 2186 siliconematerial is required.

For extra-large breast appliance sizes, an additional 40 grams will berequired to form the surface area of an inside "Pocket," or air space.In the larger sizes, the "pocket" is used to lessen the weight of thebreast appliance, particularly where both breasts are being replaced.

Again, the 2186 silicone material may be air brushed, painted orotherwise sprayed into the breast appliance front mold, as is shown inFIG. 25 where it is shown being applied with a brush. The skin siliconematerial 111 is shown as being partially painted in, and it covers thenipple silicone material 109. Both the nipple silicone material 109 andthe skin silicone material 111 may be referred to collectively as tissuesilicone material. The tissue silicone material, as has been shown,differs only in the amount and color of pigment added, and spatiallocation of the tissue silicone material within the breast appliancefront mold 89 and breast appliance back mold 85. It is important toachieve an even depth of the skin material. There are many ways tomanipulate the skin material, but it must be remembered that once thecatalyst is mixed in, the skin will begin to set in minutes.

One material which facilitates the workability of the silicone skinmaterial 111 is a product known as "200 fluid, 100 CST," which iscommercially available from Dow Corning. This material is applied to thehands before physically manipulating the silicone skin material 111 toprevent such skin material 111 from pulling away from the breastappliance front mold 89.

In addition to the breast mold surface area 91 within the breastappliance front mold 89, a thin layer of skin silicone material 111 isapplied to the rim area 95, making sure that it is continuous with theskin material 111 of the breast mold surface area 91. The edge where therim area 95 meets the breast mold surface area 91 will likely form thethickest dimension of the skin silicone material 111. This will aid inretention of shape.

Remembering that the rim area 95 is tapered, the closing of the breastappliance back mold 85 which is not tapered will cause the skin siliconematerial 111 to be squeezed thin in the direction concentrically outwardwith respect to the rim area 95. Of course, for a given degree of taper,both the breast appliance back mold and the breast appliance front mold89 could contain rims whose composite taper would add to the totalamount of taper needed. However, since the client 51's chest will beflat in the area surrounding the breast removal area, it is preferredthat the breast appliance front mold contain the tapering rim area 95.

Referring to FIG. 26, and a soon as possible after the skin siliconematerial 111 is applied to the breast appliance front mold 89, the skinsilicone material 111 is applied to the impression side of the breastappliance back mold 85. The material 111 is applied over the wholesurface, remembering that any excess will be squeezed concentricallyinwardly, and somewhat concentrically outwardly with respect to the rimarea 95.

Special care is taken to make certain that the area of the breastappliance back mold 85 immediately adjacent the tubes 103 and 105 iscompletely wetted with the skin silicone material 111. Otherwise, someof the silicone gel which will be added could seep between the skinsilicone material and the breast appliance back mold 85.

As soon as practically possible, and once the layer of skin siliconematerial 111 is properly applied to the inside of both the breastappliance back mold 85 and the breast appliance front mold 89, the moldsare brought back into mating alignment in the same position andorientation as they were when previously shown in FIG. 19. The alignmentmay be marked as in the step of FIG. 19 before the breast appliance backmold 85 is separated from the breast appliance front mold 89, to aid inre-alignment. Alignment is important not only because the breastappliance to be formed is gravitationally oriented, but because thegravitational orientation must match the chest tissue orientation of theclient 51.

Once the breast appliance back mold 85 and the breast appliance frontmold 89 are joined, it is preferable to secure them with a strap 113,the strap 113 being fixably tensioned with a buckle 115. Note FIG. 27,and the position of the breast appliance back mold 85 with respect tothe breast appliance front mold 89. This is the position which is mostadvantageous in filling the breast appliance with silicone gel.

The silicone gel used, like the nipple and skin silicone material 109and 111, may be of any type, but it is recommended to use SYLGARD brand527 primerless silicone dielectric gel which is commercially availablefrom Dow Corning. The silicone gel, hereafter referred to as gel 117 isa self healing gel, and also has a two part, "A" and "B" liquid.However, it is recommended to vary the amounts of each part to achieve avariety of structural consistencies. Although the manufacturerrecommends a 1:1 ratio for a self healing resilient gel-like mass, otherconsistencies may be sought.

Since the client 51 will normally try to match the previous breastconsistency, the consistency of the breast appliance will need to besimilarly varied. This is particularly necessary where a younger client51 desires a more rigid consistency matching an overall firm body tone,and where an older client would require a much less rigid consistency tomatch a softer body tone.

A softer tone is achieved by adding less of the "B" component. Forexample, one preferred softer formulation involves the use of 330 gramsof "A " and 270 grams of "B." The firmest combination would involveequal amounts of "A" and "B." Remember that the total volume of themixture will depend upon the size of the breast appliance to beproduced. In addition, it is preferable to make more of the gel 117,since any shortage would have to be made up by re-mixing a batch whichwould not cure evenly with the first amounts introduced into what is nowthe breast appliance mold 119, formed by the joining of the breastappliance front mold 89 and the breast appliance back mold 85.

Further, by allowing the silicone gel 117 to cure within the envelope ofthe silicone tissue material, the gel is at least partially cured to thesilicone tissue material. The silicone gel 117 significantly stronglyadheres to the silicone tissue material. This is advantageous in thatthe silicone tissue material and the silicone gel 117 material then formadditional bonds which further support and strengthen the resultingstructure. Further, the silicone gel 117 material will cure to a shapedefined by the silicone tissue material, and together they willresiliently hold their shape. This definitely prevents the cured gel 117shape from turning within the silicone tissue material envelope.

The mixed gel 117 is loaded into a syringe 121 and is forced throughtube 103 and into the breast appliance mold 119. Size of the syringe121, and size of the cavity within the breast appliance mold 119 willdetermine how many times the syringe 121 will be re-loaded before thebreast appliance mold 119 is filled. Once the breast appliance mold 119is filled, the gel 117 and bubbles will begin to emerge from the tube105. The breast appliance mold 119 should continue to be filled with thesyringe 121 until the stream of liquid from the tube 105 emerges as abubble free stream.

The breast appliance mold may be tilted and shaken to free any entrappedbubbles, in order to get them to come to the surface and exit throughthe tube 105. Once the breast appliance mold 119 is filled and free ofair, the tubes 103 and 105 are clamped to seal them, and thereby preventany air or flow of gel 117 into or out of the breast appliance mold 119.The syringe 121 will typically be removed and all gel 117 removed toease in cleaning and to keep the syringe 121 free of obstruction for thefilling of the next breast appliance mold 119. The filled breastappliance mold 119 is then left to stand, so that the setting of the gel117 will be completed. Preferably, it will be left to stand for eight toten hours, especially if such time is available.

For the larger sized breast appliances, a longer cure time, perhaps overa weekend is encouraged to make sure that curing is complete. It shouldalso be remembered that a larger sized breast appliance may require agreater degree of firmness to compensate for the larger size. A firmerbreast appliance, but having more mass, will react to forces in a mannersimilar to a smaller sized breast appliance of lesser firmness.

Once the requisite time has passed for setting to occur, the tubes 103and 105 extending from the breast appliance mold 119 are removed,usually by wedging the seem between them, and once pried partially openby grasping them and pulling them from the breast appliance back mold85. The breast appliance mold 119 is opened carefully, usually bycarefully wedging a seem 123 dividing the breast appliance back mold 85and the breast appliance front mold 89. A prying instrument may be usedto separate the breast appliance mold 119.

Remember that the separation involves the parting of plaster materialfrom the skin silicone material 111, and that the integrity of thismaterial is of paramount importance during separation of the breastappliance mold 119. Further, and of even greater importance, the mold119 must be opened carefully and in a manner that the breast applianceback mold 85 separates from the breast appliance. This should happennaturally since the mold area of the breast appliance back mold 85 isflat and will usually offer the least resistance, while the breastappliance front mold has a larger surface area which is both paralleland perpendicular to the direction of separation of the mold 119.

Once the breast appliance back mold 85 is separated, a configurationsimilar to that shown in FIG. 28 will appear. The breast appliance 125is visible for the first time, and particularly its back wall 127, andtapering edge 129. Two apertures 131 and 133 of the back wall 127 arevisible which were formerly occupied by the tubes 103 and 105. Thesewill be sealed will a further application of skin silicon material 111as will be shown later.

The removal of the tapering edge 129 portion of the breast appliance 125is of importance because of the thinness of the outer portion of thetapering edge 129. The tapering edge 129 is important to the finishedproduct because if the edge 129 is thin enough, it can optically blendinto the surrounding tissue of the client 51. Generally, the surfacefinish on the portion of the breast appliance 125 facing away from theclient 51 while being worn will have an light scattering translucence.However, when the thinner portion is wetted and held against the skin,it becomes somewhat transparent.

Since the outer finish is not shiny this transparency, which occurs morereadily at the thinner portion, provides an optical blending along aline from the client 51's natural tissue and onto the breast appliance125. Any liquid placed between the skin of the client 51 and thetapering edge 129 will cause this optical effect. The breast appliance125 will be mounted onto the client 51 with an application of liquidadhesive which will also serve to perform the same optical effect, eventhough the adhesive will "dry" or become less liquid-like as the breastappliance 125 adhered to the client 51, as will be later shown.

The thinner the radially outermost portion of the tapering edge is, themore readily will the breast appliance 125 blend into the surroundingtissues of the client. This must be balanced against the possibility oftoo thin a periphery which might tear upon the mounting and removal ofthe breast appliance 125. In any event, the tapering edge 129 willusually be difficult to removed from the rim area 95 of the breastappliance front mold 89.

It is preferred, where the removal is done by hand, to gently pullupwardly on the tapering edge 129 and to work the fingers behind andalong the tapering edge 129 to gently wrest it from the rim area 95.Once the tapering edge 129 is free, along the periphery of the back wall127 of the breast appliance 125, the breast appliance 125 may begun tobe separated from the breast mold surface area 91. This too is adelicate step to be done manually since to pull the wall of the breastappliance 125 too far from the breast mold surface area 91 could causedamage. The space between the breast appliance 125 and the breast moldsurface area 91 should be moved about the surface area between these twostructures, working toward the nipple mold area 93.

Another method for removing the breast appliance 125 from the breastappliance front mold 89, may involve the use of compressed air. It maybe forced into the area between the breast appliance 125 and the breastmold surface area 91. Going back a step, compressed air may beintroduced into the holes 99 and 101 to first separate the breastappliance back mold 85 from the breast appliance front mold 89 and theskin silicone material 111 immediately adjacent the breast applianceback mold 85. Regardless of whether or not air is initially used toseparate bulk areas of material from the breast appliance mold 119, caremust always be taken to make sure that no one area of the set skinsilicone material 111 is adhered to the inner portion of the breastappliance mold 119 so as to cause a tearing of the breast appliance.

Further, a pin hole may be formed in the breast appliance front mold atthe center of the nipple mold area 93 where a small flow of compressedair may be applied to aid in separation. Other strategically placedpinholes could be arranged to introduce a higher flow of compressed airwhich could facilitate the removal of the breast appliance 125 from thebreast appliance mold 119 in a quick and efficient manner.

Once the breast appliance 125 is freed from the breast appliance frontmold 89, it may be turned upwardly for close inspection, as is shown inFIG. 29. In this orientation, a breast surface area 135 can be seencontinuous with the tapering edge 129. The nipple surface area 137 isalso visible. The outer areas of the breast appliance are inspected todetect any problems associated with the molding process, such as bubblesin the outer surface, tears, or other anomalies.

The ragged portions of the tapering edge 129 can be trimmed carefullywith scissors to make certain that the breast appliance outer peripheryhas a smooth outer continuity. It should be remembered that too closetrimming will defeat the ability of this tapering edge 129 to blend inwith the skin of the client 51 once the breast appliance is mounted. Itis understood that the breast appliance 125 need not always beadhesively mounted onto the chest of the client 51, but that it may beworn loosely adjacent the surgical area with a bra. This is especiallywhere due consideration is given to the shape of the breast appliancewith regard to the client 51's bra and cup size is taken to account.

Referring to FIG. 30, a view of the back wall 127 of the breastappliance is shown, and which illustrates a tapering edge 129 which hasbeen trimmed and which ideally has a somewhat uniform radial dimension.The apertures 131 and 133 have been covered with an identifying label139 which may be used to distinguish between owners, manufacturers, typeof gel 117 fill, and other identifying information. The material whichmay be used to perform this sealing is commercially available from DowCorning Corporation and sold under the name SILASTIC medical adhesive,type A, and identified with the catalog number 891. This adhesive isspecifically intended for bonding silastic elastomers. The label 139 isthen painted over with a small amount of skin silicone material 111, andallowed to set. This then seals the gel 117 within the breast appliance125.

FIG. 30 also shows an amount of liquid adhesive 141 being brushablyapplied to the back side of the tapering edge 129 in anticipation ofmounting of the breast appliance 129 onto the client 51. The adhesivepreferred is commercially available from Dow Corning as a medicaladhesive No. 355 and commercially known under the name SECURE ADHESIVE.The adhesive is preferably laid down in an elongate continuous bead. Onesuch adhesive which has proven effective is commercially available fromReferring to FIG. 31, and once the adhesive 141 has been applied alongthe total length of the tapering edge 129, the breast appliance 125 isoriented properly and pressed in place on the chest of the client 51.The outer periphery of the tapering edge 129 is shown in dashed lineformat to indicate that the outermost periphery of the tapering edge 129will usually not be visible unless viewed extremely closely. Althoughthe transition between the tapering edge 129 and the breast surface area135 is shown about the periphery of the breast appliance 125, thistransition is usually more obscure and undetectable.

Details may added to the skin silicone material 111 and to the gel 117area to further cause the breast appliance 125 to have a more naturalappearance. For example, where the client 51's skin is somewhat morevein like, a length of blue flocking can be laid alongside the skinsilicone material 111 before the breast appliance mold 119 is closed,before the gel 117 is introduced. Later introduction of the colored gel117, in addition to the coloring of the skin silicone material 111 whichthe flocking will lie behind once the breast appliance 125 is removed,will cause a vein-like appearance to appear, shown in FIG. 31 as veins143. The look of the veins 143 may be adjusted depending upon thediameter of the flocking and how loosely it is oriented with respect tothe skin silicone material 111.

Where the client 51 has freckles, they may be "painted onto" the skinsilicone material 111 in a variety of ways. There are some freckleswhich have a sharp definition. These freckles would be painted onto thebreast mold surface area 91 prior to painting on the main layers of theskin silicon material. Freckles having a medium amount of definitionbetween the freckle color and surrounding skin color could be formed byfirst applying a very thin layer of skin silicone material, followed bya hand painting in of the freckle material, followed by a finalapplication of the skin silicone material 111. In the most obscurecases, more skin silicone material 111 is left between the breast moldsurface area 91 and the applied freckle color silicone material.

Once the breast appliance 125 has been adhesively placed onto the client51, it need not be removed more than as necessary for personal hygienein cleaning the area of the skin covered by the breast appliance 125.When used with an adhesive, the client 51 can swim, jog, etc. withoutworry of displacement of the breast appliance 125.

In some instances, it may be necessary to enable air to come intocontact with the scar tissue 71 for a given period after surgery. Inthis instance, the breast appliance 125 can still be worn daily, withoutthe adhesive 141, and secured with a bra. In this manner, the client 51can begin to become accustomed to again having an upper body breastweight while the tissue around the scar tissue 71 continues to heal.

The processes described thus far have been selected to illustrate themost complete set of circumstances having the most steps andopportunities for capturing a client 51's physical likenesses, wherethose likenesses were available pre-operatively. In other instanceswhere less than all of the client's likenesses are availablepre-operatively, the methods described herein are modifiable to stillgive an advantageous result.

The next instance where some modification is necessary is the instancewhere the client 51 has had a single mastectomy. In this instance, asingle breast is available for molding. When a negative body mold 61 ismade, it will contain the negative mold of the existing breast on oneside and a negative mold of the post operative chest area, on the otherside similar to the post operative negative body mold 73. Becausebreasts are not identical, and only exhibit bi-lateral symmetry, theexisting breast cannot normally be used to produce a direct mold of theopposite breast. However, the nipple 63 is normally directly moldablefor inclusion on the other breast.

In this case, the client 51 has a post operative negative mold 75prepared, as was shown in FIGS. 7-9, and a resulting positive body moldprepared therefrom as was shown in FIG. 10. However, the result is apositive body mold 151 as is shown in FIG. 32. The positive body mold151 has a natural breast form 153 and a scar tissue form 155 adjacenteach other. Clay can be used to sculpt a clay breast form 157, shown inFIG. 33, or clay can be pressed in an impression material and thenplaced on a surface for continued reshaping and sculpting.

An amount of clay is placed atop the positive body mold 151, and shapedinto a form mirroring the shape of the natural breast form 153. The claybreast form 157 can then be easily lifted from the positive body mold151 without upsetting its shape. Further, since it is sculpted andshaped while atop the scar tissue form 155, its rear end will have ashape which will fit perfectly over a breast appliance back mold 85. Thesculptor can make measurements and shape comparisons upon the positivebody mold 151 by using the client 51's bra. If the positive body mold151 was taken while the client 51 was in a standing position, and if theclay breast form is made to match, the breast appliance 125 formedtherefrom may not be suitable for use with a bra. In this case, a secondclay breast form 157 may be desirable to make a second breast appliancewhich would fit more readily inside a bra. This difference is to takeaccount of more marked differences in the position of breast as wouldoccur with and without a bra. If the two positions are sufficientlysimilar, a single breast appliance 125 can serve the client 51 whilewearing a bra or without. The ability to have a positive body form 151with a natural breast form 153 for comparison greatly enhances theability to judge these differences.

It is advisable that once the clay breast form 157 is shaped, it not beplaced on a flat surface, which might obscure the shape taken from thenatural breast form. It is therefore recommended that the steps shown inFIGS. 11-14 be first performed to form a breast appliance back mold 85.This will involve the formation of an alginate layer on the postoperative body mold 151 rather than 75, and the formation of the breastappliance back mold 85 in a manner similar to that shown in FIGS. 12-14.

Thus, if the breast appliance back mold 85 is in position, the claybreast form 157 may be gently moved from the positive body mold 151 tothe breast appliance back mold. If the clay breast form 157 is to bestored for a period of time, it is desirable to keep it moistly wrapped,as for example by a damp cloth. This will prevent shrinkage and unevenhardening.

Next, the nipple mold 67 taken as shown in FIG. 6 may be used to form anipple. In the present case where one breast is available, the nipplemold 67 may be made from the client 51's existing breast. Although thenipple material may be made from the nipple atop the natural breastform, it should be remembered that this would produce a nipple takenfrom a positive plaster mold to alginate, and back to silicone. Sincethe client 51 is available, it is advisable to take one or severalalginate negative molds of the client 51's nipple, and to then make thesilicone nipples by directly painting nipple silicone material 109 intothe alginate layer 53, which was shown in FIG. 6. Since virtually all ofthe finish errors occur from using plaster, a direct silicone onalginate mold will produce the best quality silicone nipple.

Referring to FIG. 34, a silicone nipple 159 so formed and trimmed isplaced atop the clay breast form 157. In working with the clay, there isan additional advantage in that the edges of the silicone nipple 159 maybe "worked" with respect to the clay to give a seamless transition fromthe silicone nipple 159 material to the clay material.

Where the silicone nipple 159 has a tapering edge, similar to thetapering edge 129 of the breast appliance 125, the transition from theedge of the silicone nipple 159 to the clay material of the clay breastform 157 may not need as much working to blend. Even where a smalltransition is left, the effects of the transition can be correctedduring the inside finishing (sanding) of the breast appliance front mold89 which will be formed.

In FIG. 34, the clay breast form 157 sits atop the breast appliance backmold 85, with the flexible barrier 81 being applied about the breastappliance back mold 85, in preparation to form the breast appliancefront mold 89 as was shown in FIG. 17-19. The steps to form the breastappliance 125 are identical for the steps following FIGS. 17-19 andinclusive of FIGS. 20-31.

In a third general case, the client 51 has had surgery which has removedbreast mass, but left the client 51's nipples in place. Often in thiscase the client 51's nipple can be extremely sensitive to touch. Assuch, any structure or appliance positioned to cause contact andtouching movement to the client 51's nipple is to be avoided. Althoughthe advantages from an exact fit over the client 51's chest are manyfrom the standpoint of good fit, and movement with rather than againstclient 51's tissue, where the client 51's nipple is sensitive hasoverriding concerns. In any event, and especially where sensitivity isan issue, the range of expected motion of the client 51 which wouldproduce undue disturbance of the nipple is not expected to be as great,and therefore the loss of close cooperation with the client 51's tissuesadvantageous in significant physical activity is not as important.

The breast appliance 125 formed in consideration of the sensitive nipplewill have a spatial pocket formed in the rear area of the breastappliance which will fit over the client 51's nipple. Recalling the postoperative mold taken with regard to FIGS. 7-9. Instead of purely scartissue 71, there will be some scar tissue and nipple tissue present.This is shown in FIG. 35. Positive body mold 75 is now shown as havingscar tissue surrounding a pair of post operative nipple shapes 161.Typically the scar tissue will extend linearly downward away from thenipple area of the breast, and often around the nipple areolar. Theareas which the client 51 indicates are sensitive are noted and notedwith respect to the positive body mold 75 or 151.

Once the positive body mold 75 or 151 is formed, the sensitive tissueareas are identified. An amount of clay 161 sufficient to form a pocketpresenting a significant depth with respect to sensitive tissue isformed atop the nipple shapes 161 to ensure that the subsequently formedbreast appliance 125 will significantly clear the client 51's nipple. Byusing clay applied over the positive body mold 75 or 151, severaladvantages can be obtained. First, using a positive material will enableease of sculpting and can allow for the formation of a small surfacearea, deep pocket, or a gradually sloping volume covering a wider area.

Referring to FIG. 36, the use of the small amount of clay 163 on thepositive body mold 75 is illustrated. The use of the clay 163 on thebreast appliance back mold 85 is not advisable because there may be someproblems associated with application of the skin silicone material 111to the clay material. Also, since the breast appliance mold 119 will beclosed and will be filled with the surface of the breast appliance backmold 85 oriented downward, it may be difficult to keep the small amountof clay 163 in place. In any event, it appears as if the use of thesmall amount of clay directly onto the positive body mold 75 ispreferable.

Once the small amount of clay 163 is in place, an alginate mold can beprepared from the positive body mold 75, as was shown with respect toFIGS. 10-13. This will produce a breast appliance back mold 85 having arise 165, as is shown in FIG. 37. The breast appliance back mold 85 isthen used in conjunction with a breast appliance front mold 89 toproduce the breast appliance 125. Note that if a clay breast form 157 isused, and utilizing the positive body mold 75 as a support base, thesmall amount of clay 163 should be kept separate from incorporation intothe base of the clay breast form 157 so that the clay breast form 157will fit atop the breast appliance back mold 85 without furtherformation changes to accommodate the rise 165.

The next step, according to the sequences of FIGS. 15-19, would be theformation of the breast appliance 125 by pouring a plaster volume overthe breast appliance back mold 85 while a clay breast form 157 is inplace with respect to the breast appliance back mold 85.

Referring to FIG. 38, a sectional view taken along line 38--38 of FIG.26 illustrates a sectional view of a breast appliance 125 having both anipple clearance pocket 167 and a nipple enclosed air pocket 169. Thenipple enclosed air pocket 169 was formed by leaving a bubble of airwithin the outermost and concentrically inner most portion of the nipplemold area 93 as was discussed with regard to FIG. 24. The silicone gel117 is visible as well.

In the fourth case, the client 51 has previously had a doublemastectomy, and has neither a breast size nor shape reference. Further,the client 51 has no nipple shape reference from which to mold a nippleform. In this case, the client 51 has a post operative positive bodymold 75 made, as was shown in FIGS. 7-9. From the positive body mold 75,the client 51 can direct the molding of a natural breast form of a sizeand shape to suit a variety of tastes.

Some considerations may include the need for a reduction in size fromthe client 51's previous post operative breast size. The degree ofactivity of the client 51 may also cause a smaller size to be of greaterutility. A breast appliance 125 having a lesser depth, but wider rearsurface area may be more advantageous for the active client 51.

With regard to a selection of a nipple shape and size, a nipple form canbe sculpted artistically from scratch, and then molded to form asilicone nipple 159 which can then be placed atop the clay breast form157 as was shown in FIG. 34. In the alternative, a wide array of nippleshapes will be available from previous clients 51, any one or pair ofwhich may be selected for use, typically in the form of a siliconenipple 159.

FIG. 39 illustrates the formation of a silicone nipple 159 using thesmall portions of the alginate material 53 supported by a small amountof plastic bandages 55. In the case of the formation of silicone nipple159 only, it will usually not be necessary to have the rear portion ofthe silicone nipple 159 exactly match the client 51's area ofattachment. This is because the area of attachment is relatively largecompared to the mass of the silicone nipple 159.

Where the client 51 has internal implants, the use of silicone nipples159 is quite desirable. The silicone nipples 159 are formed by pouringnipple silicone material 109 directly into the negative nipple mold 67formed as shown in FIG. 6 to form a smooth backed surface area 171. Toform a surface area 171 which matches the client 51 tissue, a mold ofthe client's tissue at the area where the silicone nipple 159 is to beattached can be made with alginate 53 and bandage 55 similar to thatshown in FIG. 6, which will capture any details of the nipple attachmentarea, such as scar lines and troughs. Once a positive plaster mold 173of the client 51 implant tissue area is made, it may be gently placedagainst the surface area 171 at the time the silicone nipple material109 is poured into the nipple mold 67, as is also shown in FIG. 39.

Once the silicone nipple 159 is formed, it may be applied to the client51's tissue using liquid adhesive 141 as was shown for the breastappliance 125, except that the liquid adhesive 141 should cover theentire surface area 171 of the silicone nipple 159.

While the present invention has been described in terms of a breastappliance and manner of making same, one skilled in the art will realizethat the structure and techniques of the present invention can beapplied to many situations and instances. The present invention may beapplied in any situation where a prosthesis or appliance of a givenconsistency is to be formed.

The methods thus far discussed involve the taking of impressionsdirectly from the skin surface of a client 51. Such direct impressionsenable the replication of skin topography, including fine details of thenipple 63, areolar 65, scar tissue 71, and so on. The alginate layer 53enables the capture of the topographical features, both post andpre-operatively to enable the breast appliance 125 to match the postoperative tissues of the client 51, and to enable the frontal surfacesof the breast appliance 125 to closely approximate the client 51's ownnatural tissues if any were available for molding, pre-operatively.

Other methods are available for obtaining the client 51's topography andmass. Beginning at a crude level, positions on a client 51's torso canbe digitized using a variety of digitization methods. Referring to FIG.40, a client 51's chest area is digitized using a probe 181. Theclient's breast 183 is being digitally mapped with the probe 181. Shownis a series of data points over laid on the client's breast 183. Sincenaturally occurring points are to be taken, care must be had in notcompressing the tissues of the client 51 to insure that a map of thetopography of the client 51 is had accurately.

Further, an unlimited number of data points may be taken across thechest, neck and stomach areas to insure that a whole picture is had ofthe client 51's form. Using reference points of note, including theoutermost tip of the nipple 63, positions on the client 51's clavicle,the client 51's navel, etc. a topological map relative to these keypoints can be obtained. As is shown in FIG. 40, these data points can beused to machine a negative body mold 57, or a positive body mold 61 (notshown in FIG. 40), which can then be further processed.

With the ease of taking topological data points, and the advantages ofreference points of note, it is also possible to take these topologicaldata points while the client 51 is in other positions, including bendingover and lying down. These can be taken with an eye to forming a breastappliance 125 which will react more naturally. These more naturalreactions may include axial elongation on bending over, frontal anddownward loading on standing, and flattening out when reclining or lyingdown. Once points for these positions are taken, the differencing ofthese points will indicate the natural physical displacement of thebreast 183 tissue mass. Once the natural physical displacement of thebreast 183 tissue mass is known, the gel 117 within the breast appliance125 can be cured in layers, or differentially cured to produce thecorresponding natural physical displacement.

Aside from taking individual data points, other methods exist which canmap the client 51's chest as a whole are known, which will enable asingle scan to take an extremely high number of data points or otherindicia of topography with far less effort. Further, rather than datapoints, vector information may be gathered to more adequately describethe chest of the client from a "sculptural" viewpoint, as will beexplained.

The taking of the data points, or topographical information in thismanner will eliminate the need for a negative mold 57, positive bodymolds, including the pre-operative positive body mold 51 and postoperative positive body mold 75. In this case, the breast appliance mold119 can be CNC or computer numerically controlled machined from anysuitable material. If machined, the portions of the breast appliancemold 119 need not have a seem which is generally radial to the breastappliance 125 axis.

Further, the internal breast surface areas 91 and nipple mold areas 93can be machine finished to any desired surface finish. Other surfacedetails, such as freckles and moles which would be labor-intensive toadd to the skin silicone material 111 can be done automatically bymachine, because the size and shape and color of each freckle will beknown to an extreme accuracy. Of course, further matching, and an entirepallet of colors equivalent to the client's colors would need to begenerated. However, such multiple color matching and blending is simpleto perform once the colors and location of the coloring are scanned intoa computer 185, shown schematically in FIG. 40.

A variety of different wavelengths of light could be use to illuminateand color match the freckle type areas to insure that the colors werematched for different types of lighting and had a statisticaldistribution matching the client 51's skin.

Of course, if it were desired, the spatial representation of the client51's chest area could be made into a positive body mold 61 forillustration purposes. Further, through the use of computer graphictechniques, the client 51's pre-operative torso area could be displayedon a screen, for subsequent manipulation and changing of the breast formof the client 51 before formation of the breast appliance mold 119 andbreast appliance 125.

An optical scan is shown in FIG. 41 and illustrates a scanner 191scanning the torso and breasts 183 of the client 51, into the computer185. A similar optical scan can be taken post-operatively anddifferenced with respect to the pre-operative scan. Such as techniquehas the advantage of defining the outermost regions, taken concentric tothe client 51's breast, for which a change has occurred. This willenable the formation of a breast appliance having significant deviationsfrom radial constancy, particularly with respect to the back wall 127 ofthe breast appliance 125, especially since some body forms includesignificant undercuts resulting from a significant overhang.

In some breast forms, there is a significant overhang of the bottom ofthe breast onto the lower rib cage. These can be difficult to properlymold. Often, one breast appliance 125 is provided for the standing,bra-less configuration, while another is provided for the bra-coveredposition. A more thorough scan of the client 51 topology, particularlyin bending, standing, and lying position, will enable a breast applianceto be made which will most closely approximate the client 51's naturalbreast 183.

This is easier to accomplish in the case of firmer breasts and mostdifficult in the case of softer breasts which have extreme positionaldisplacement on change of body position. The gel 117 mass may be allowedto cure in layers having a shape which facilitates positionaldisplacement of the layers in a manner which will approximate the changein position and shape of a natural breast under the influence of achange in a client 51's position. One such orientation would involve theformation of gel layers using a separating, removable divider to preventcuring between the layers. This configuration is shown in FIG. 42.

This sectional view illustrates the gel 117 as divided into layers 195,each layer 195 having the ability to slide with respect to adjacentlayers 195. The layers 195 may or may not be set with respect to theskin silicone material, especially the layers 195 in between the forwardmost and rearward most layers 195. This sliding plate action will enablethe breast appliance 125 to move radially about in a more naturalmanner. Beyond this simplicity, the complex motions captured by thescanner 191 can enable layers 195 other than a set of parallel layers195 to be incorporated into the breast appliance 125. The specificlayering will be determined by the central amounts of tissue of theclient 51, and the direction of displacement under differinggravitational influences and client 51 movement.

Another option to the breast appliance 125 of all embodiments of thepresent invention is also shown in FIG. 42. An insulative pad 197 isincludable onto the back wall 127 of the breast appliance 125. Theinsulative pad may be thin enough to accommodate the shape of the backwall 127 and the scar tissue 71 of the client 51 so as to not mitigatethe advantage of having matched surfaces. An insulative pad is oftendesirable in very hot or very cold weather.

In cold weather, the relatively large surface area of the breastappliance 125 will tend to lose heat faster than the surface of theclient 51's tissue to which it is attached. This can cause a cold spoton the client's chest in its area of contact with breast appliance 125,which can be uncomfortable. Similarly, excessive heat can be transmittedto the client's chest, with no opportunity for expiration andevaporative cooling. Insulative pad 197 can prevent undue cooling andundue heating provided it gives sufficient resistance.

As a further alternative, a heat resistant material could be applied tothe skin silicone material 111 just after the skin silicone material isapplied to the breast appliance back mold 85. Since the cured siliconegel 117 will not circulate within the breast appliance 125, aninsulative pad 197, if placed within the skin silicone envelope canstill function to block heat. This internally placed insulative pad 199is shown in FIG. 42 in dashed line format.

Although the invention has been derived with reference to particularillustrative embodiments thereof, many changes and modifications of theinvention may become apparent to those skilled in the art withoutdeparting from the spirit and scope of the invention. Therefore,included within the patent warranted hereon are all such changes andmodifications as may reasonably and properly be included within thescope of this contribution to the art.

What is claimed:
 1. A breast appliance for conformance to the chestsurface of a wearer comprising:a mass of partially cured silicone; alayer of skin silicone material enveloping and cured with and to saidmass of partially cured silicone, such that said mass of partially curedsilicone will not separate from said layer of skin silicone, a portionof said layer of skin silicone material having a back wall molded toconform to an impression taken from the chest of the wearer, said backwall having a tapering edge about the periphery of said back wall toassist in blending said breast appliance into an area of surroundingskin of said wearer, said skin silicone material having a front portioncontinuous with said tapering edge of said back wall and having a firstshade of color additive dispersed within a volume of material of saidskin portion of said front portion, and having a second shade of coloradditive different than said first shade of color additive dispersedwithin a volume of material of a nipple portion of said front portion ofsaid skin silicone material, said nipple portion continuous with andcured to said skin portion and having a greater hardness than said skinportion of said front portion of the layer of skin silicone materialand; wherein a third shade of color additive is dispersed throughoutsaid mass of partially cured silicone; and wherein said first and saidsecond and said third shades of color additive are a face powderdispersion color additive and form a suspension having color and depthtones comparable with a surface color and a depth of skin tone of saidwearer.
 2. The breast appliance recited in claim 1 wherein said breastappliance is made for fitting over a post operative surgical area ofsaid wearer resulting from removal of a breast of said wearer andwherein said front portion, including said skin portion and said nippleportion of said layer of skin silicone material has an outward surfacetopography physically measured from an outward topography of said breastof said wearer.
 3. The breast appliance recited in claim 2 wherein saidlayer of skin silicone material of said back wall has an outward surfacetopography physically measured from a post surgical area outwardtopography of said wearer.